Cardiovascular disease subjects either with established disease or at high risk
Conditions
Interventions
Product Name: Red Heart Pill Version 1c
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: aspirin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 75-
INN or P
Sponsors
Imperial College
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All subjects recruited to European centres for the UMPIRE study are eligible for inclusion in PESCA. The Umpire inclusion criteria are: adults (over 18 years) participant capable of giving informed consent established atherothrombotic cardiovascular disease ore high cardiovascular risk, defined as: history of coronary heart disease (myocardial infarction, stable or unstable angina pectoris, or coronary revascularisation procedure), or history of ischaemic cerebrovascular disease (ischaemic stroke or transient ischaemic attack), or history of peripheral vascular disease (peripheral revascularisation procedure or amoputation due to vascular disease) OR For individuals without established cardiovascular disease, a calculated 5 year CVD risk of 15% or greater (calculated using the 1991 Anderson Framingham risk equation with adjustments as defined by the New Zealand Guidelines Group recommendations) The trial investigators consider that each of the polypill components is indicated the trial investigator is unsure as to whether a polypill-based strategy or usual care is better Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Individuals will not be eligible for PESCA if they are deemed ineligible for UMPIRE
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary aim of the PESCA study is to determine whether a reported difference in adherence to medication (reflecting the convenience and simplicity of a 'polypill' strategy when compared with taking multiple tablets) translates into measurable effects on atherosclerosis and central systolic blood pressure. Atherosclerosis (fatty deposits and thickening of the arterial blood vessel walls) and central blood pressure (pressure in the the body's main central artery - the aorta) are both major indicators of cardiovascular disease risk. ;Secondary Objective: In the UMPIRE study, measurement of blood cholesterol levels and peripheral blood pressure will be used to validate information provided by participants about their adherence to medication. Atherosclerosis, measured by arterial wall thickness (CIMT), and central systolic blood pressure are more direct indicators of cardiovascular risk than blood cholesterol and peripheral blood pressure. It follows that the PESCA measurements will provide additional validation of the UMPIRE findings.;Primary end point(s): The primary outcomes measures for the PESCA study are: 1. Change in intima-media thickness (IMT)in the common carotid artery from baseline to end of trial follow-up. 2. Change in intima-media thickness (IMT) and extent of atherosclerotic plaques in the carotid artery bifurcation (carotid bulb) from baseline to end of trial follow-up 3. Change in central aortic systolic blood pressure from baseline to end of trial follow-up. | — |
Countries
United Kingdom
Outcome results
None listed